Scott Krygier

Scott Krygier is of counsel at Moarbes and part of the Life Sciences Practice. Dr. Krygier and the head of the life sciences practice, Mr. Mason, have combined their collective 30 years of outside counsel legal expertise with practical knowledge gained by working in business to efficiently counsel clients on a comprehensive strategy for FDA and USPTO approval, along with downstream success in threatened or actual litigation. Given the FDA favors conventional extensions of existing treatments, whereas the USPTO and Federal Courts favor patents on the most unconventional and non-obvious such treatments, Dr. Krygier and Mr. Mason firmly believe a comprehensive strategy resolving that tension is critical to the long-term success of any life sciences company.

Dr. Krygier’s expertise is counseling pharmaceutical, medical device, and biotechnology clients for over the past decade on issues related to compliance with the laws and regulations administered by FDA, USDA, and EPA.

Dr. Krygier’s clients vary from the earliest to latest stages, i.e. from early product development and optimization to commercialization.  


Provided innovative regulatory approaches seeking approval for a monoclonal antibody therapy for a cancer market worth $42 billion, well-received by the FDA.

Provided regulatory approaches for cell therapies for the CAR-T market worth $72 million, also well-received by the FDA.  

Provided regulatory approaches seeking approval for gene therapies in a cancer market worth $30 million, also well-received by the FDA.

Provided advice and strategy on how to present pre-clinical data to the FDA to demonstrate safety in an IND to proceed to a first-in-human. Phase I trial was successful, not requiring any additional studies to be performed and keeping to the 30-day review time stipulated by regulation.

University of Maryland at Baltimore School of Law (J.D., 2005)
Georgetown University (Ph.D., Department of Cell Biology, 2001)
State University of New York at Buffalo, Buffalo, N.Y. (B.A., Anthropology, cum laude, 1990)